R&D Administrator

PCI TRGR Penn Pharmaceutical Services Ltd; León; On-site; EUR 25,000 - 38,000; Full time

Job summary

PCI Pharma Services is seeking an organized Documentation & Compliance Administrator in Spain to maintain R&D documentation, generate controlled documents, and support change controls and reporting. You will work with cross-functional teams to ensure traceability, accuracy, and regulatory compliance.

The role requires familiarity with cGMP, strong MS Office and Smartsheet skills, and the ability to handle multiple tasks with precision in a fast-paced environment.

Qualifications

• Essential associate degree or higher in a relevant field.
• Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and Smartsheet.
• Familiarity with cGMP documentation practices and document control systems is highly desirable.
• Creative with the ability to work with minimal supervision and balance with independent thinking.
• Honesty, integrity, respect and courtesy with all colleagues.

Responsibilities

• Document Management and Control – Organize, scan, archive, and maintain R&D department documentation with traceability and version control.
• Documentation Issuance – Generate forms, templates, labels, logbooks, and documentation for trials and development activities.
• Data Management and Reporting – Maintain departmental databases and prepare process charts and trend analyses.
• Change Control Support – Coordinate basic change controls and update documentation with project teams.
• Protocol and Report Preparation – Prepare simple protocols and reports using approved templates.
• Production Data Collection and Analysis – Collect data from manufacturing equipment and generate process charts.
• Training Administration – Monitor training compliance and maintain training records.
• Personnel Administration – Assist onboarding/offboarding and maintain records.
• Procurement and Shipment Coordination – Manage purchase orders and organize R&D shipments.
• Continuous Improvement – Identify opportunities to improve documentation workflows and compliance.
• Compliance – Adhere to company policies and GMP requirements.

Skills

cGMP documentation practices

Document control systems

Microsoft Office

Smartsheet

Organizational skills

Communication skills

Interpersonal skills

Education

Associate/Bachelor level degree

Tools

Smartsheet

Excel

Word

PowerPoint

Teams

Outlook

SharePoint

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main responsibilities

• Document Management and Control – Organize, scan, archive, and maintain R&D department documentation. Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements.
• Documentation Issuance – Generate and issue forms, templates, labels, logbooks, and documentation associated with R&D trials, equipment runs, engineering batches, manufacturability studies, and pre-stability studies.
• Data Management and Reporting – Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems. Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses.
• Change Control Support – Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.
• Protocol and Report Preparation – Prepare simple protocols, reports, and controlled documents using approved templates and departmental standards.
• Production Data Collection and Analysis – Obtain and compile primary data from manufacturing equipment in accordance with cGMP requirements and internal PCI procedures. Generate process monitoring charts and supporting documentation.
• Training Administration – Monitor training compliance within the R&D department and support the creation, maintenance, and filing of training records.
• Personnel Administration – Support onboarding and offboarding activities for R&D personnel and maintain associated administrative records.
• Procurement and Shipment Coordination – Manage purchasing requests, monitor purchase orders, coordinate receipt of materials and samples, and organize R&D shipments, including samples and development materials.
• Continuous Improvement – Identify opportunities to improve documentation workflows, administrative processes, and departmental practices to enhance efficiency and compliance.
• Compliance – Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable cGMP regulations.

Work Experience and Skills Required

Essential Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.

Demonstrated ability to manage multiple administrative tasks simultaneously while maintaining a high level of accuracy and attention to detail.

Strong organizational, communication, and interpersonal skills with the ability to interact effectively across multiple departments.

COMMUNICATIONS & CONTACTS: Works directly with R&D management, scientists, technicians, and project teams. Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments. Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controls Ability to work independently and collaboratively within a multidisciplinary pharmaceutical development environment.

Qualifications

• Essential Associate Degree, Vocational Training, or Bachelor's Degree
• Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.
• Honesty, integrity, respect and courtesy with all colleagues.
• Familiarity with cGMP documentation practices and document control systems is highly desirable.
• Creative with the ability to work with minimal supervision and balance with independent thinking.
• Resilient through operational and organizational change.
• Ability to work in a dynamic, fast-paced work environment.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.

We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.